Consultant, NSF Health Sciences Pharma Biotech

Email: pharmamail@nsf.org
Phone: +44(0)1751 432999
Country: United Kingdom

Roger Guest is a registered pharmacist who has held senior leadership roles within R&D, manufacturing and QA with several blue chip pharmaceutical and biotechnology companies. He has worked extensively in Europe and the U.S.

His global roles have included leadership of R&D Good Manufacturing Practice (GMP) compliance teams and at a manufacturing facility level, membership of the site leadership teams.

Dr. Guest also has QA experience at department, manufacturing site and corporate levels both within R&D and production.

Dr. Guest’s areas of expertise include:

  • Development of IMPs and biologicals from initial formulation through clinical trials and validation to full commercial manufacture
  • Transfer of products from R&D to manufacturing
  • Design and implementation of new sterile manufacturing facilities
  • Active pharmaceutical manufacturing: Complying with cGMP requirements
  • Auditing specialization in GMP and due diligence
  • Incident management: Troubleshooting and problem solving to root cause Rapid response to global quality issues
  • Quality management systems: Development through simplification
  • Quality leadership: Promoting that quality makes sense for a better business and helping quality departments integrate their plans with site business plans
  • Application of Lean Six Sigma tools to reduce errors and continuously improve processes
  • Inspection preparation for FDA, MHRA and other agency inspections (GMP and PAI), including one-to-one preparation clinics
  • Group training and one-on-one coaching for quality management understanding and application
close